Ventricular Arrhythmias After Self-Expanding Transcatheter Pulmonary Valve Replacement: A Report From the SERVE Registry.

BACKGROUND

Two self-expanding transcatheter pulmonary valves (SETPVs), Harmony TPV (Medtronic) and Alterra Adaptive Prestent System with the Sapien 3 Valve (Edwards Lifesciences), treat pulmonary regurgitation in patients with a native or surgically repaired right ventricular outflow tract. Ventricular arrhythmias (VAs) are common after implantation.

OBJECTIVES

The purpose of this study was to identify the incidence of and risk factors for VA in the first 6 months after SETPV implantation.

METHODS

The multicenter SERVE registry included SETPV implantations at 25 U.S.

CENTERS: VA was defined as nonsustained ventricular tachycardia (VT), sustained monomorphic VT, polymorphic VT, or >1% ventricular ectopy on Holter monitoring.

RESULTS

A total of 513 SETPV implants (359 Harmony, 154 Alterra) were collected, with a median age of 28 years (Q1-Q3: 17-44 years) and no difference in baseline VA by valve type. Alterra patients were more likely (37%) than Harmony patients (26%; P = 0.014) to have VA during the procedural admission. At 6 months, predicted probability of VA burden decreased below baseline for Harmony patients (-6%; 95% CI: -10% to -2%; P < 0.001) and to baseline for Alterra (P = 0.53).

CONCLUSIONS

This large multicenter registry study of the natural history of VA after SETPV implantation showed VA to be frequent during the procedural admission, with Alterra patients having more VA than Harmony patients. VA burden decreased to lower than baseline at 6 months in Harmony patients and to baseline in Alterra patients.